Medical board's proposed stem-cell policy under fire

By Todd Ackerman |
April 8, 2012
| Updated: April 9, 2012 12:11am

Texas' proposed adult stem-cell regulations, up for approval this week, are under fire for circumventing the Food and Drug Administration and making the experimental therapy commercially available before it's been proven safe and effective.

"Texas officials should take the FDA's regulatory power over stem cells more seriously," editorialized Nature. "If the medical board were to act according to its stated pledge to protect patients, then it would make clear the need for clinical validation of adult stem cells before use and rescind the medical licenses of any doctors in breach of rules about using unapproved treatments."

The policy, thought to be the first of its kind, would allow Texas doctors to provide the unlicensed therapy as long as they have approval from a review panel that assesses the cells' use for patient safety, as is customary in clinical trials. But unlike most clinical trials, in which experimental therapy is provided free, the policy would allow Texas doctors to charge for it, typically tens of thousands of dollars.

Mari Robinson, executive director of the Texas Medical Board, denied that the proposed policy represents an alternative path than the FDA. She said that in the absence of definitive direction from the FDA, the board simply wants to ensure that "new and expanding areas of medicine" are safe for patients.

"The FDA has provided no definitive statement about the medical use of adult stem cells, including whether it even has jurisdiction if the cells are taken from patients and given back within the state," said Robinson. "The board wants to let the field come forward and grow but in a safe manner."

Robinson, a lawyer, said the courts ultimately may provide the answer about the FDA's jurisdiction. The federal agency last year filed an injunction to stop a Colorado clinic from treating patients with their own stem cells, arguing its failure to comply with FDA regulations "puts the public's health at risk."

Adult stem cells are cells in the body that multiply to replenish dying cells. Though they lack the ability of embryonic stem cells to morph into any kind of tissue, they have shown much promise in recent research treating a variety of conditions. Still, the therapy is mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

Clinics popping up

Nevertheless, clinics that claim adult stem-cell therapy can treat conditions from Parkinson's to multiple sclerosis are proliferating, mostly in other countries but increasingly in the United States. The head of a Houston stem cell bank involved in Perry's procedure says it has stored more than 100 customers' stem cells, as many as 50 of whom have had them reinjected.

The Texas Medical Board has grappled with the issue since before a Houston surgeon treated Perry last July. Its policy was tentatively approved in February, after months of "stakeholder" discussions, public comment and revision.

But numerous experts in bioethics, stem-cell science and health law last week strongly criticized the finished version. Most expressed concern about why Texas feels the need to set up a process they described as redundant to the one already run by the FDA.

"It also confuses clinical research, which is conducted to find out generalized information about new therapies' safety and efficacy, with the practice of medicine, which is about using safe, proven methods to treat ailments," said Douglas Sipp, head of Science Policy and Ethics Studies at Japan's RIKEN Center for Developmental Biology. "Essentially, Texas is saying research can be done as treatment, that patients can be charged to participate in research."

Trials threatened?

Robinson disputed the suggestion that every therapy a doctor provides requires FDA approval. She said there already are plenty of alternative and complementary medicines regulated by the state, not the FDA.

Sipp said the policy would make it difficult to conduct randomized trials, the gold standard of research in which some patients receive the therapy and some receive a placebo. Patients paying tens of thousands of dollars for therapy likely wouldn't accept a 50-50 chance of getting a placebo, he noted.

Experts also questioned the policy's allowance of for-profit review boards to oversee doctors' use of stem-cell therapies, claiming such boards risk losing business if they don't approve clinical research proposals.

The Texas Medical Board is scheduled to consider the proposed policy Friday.